Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers (MASTIHA-OIL)

Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers: a Prospective, Randomized, Placebo-controlled Study (MASTIHA-OIL Study)

A prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia; Hyperlipidemias
• Intervention / Treatment: Other: Placebo; Dietary supplement: Chios Mastiha essential oil

Detailed Description

Background Chios Mastiha essential oil (CMO) is a natural product extracted from the resin of Mastiha, possessing antioxidant, anti-microbial, anti-ulcer,anti-neoplasmatic and cholesterol lowering capabilities in vitro, and its hypolipidemic effect was confirmed in animal studies. Yet, there are no randomized, placebo-controlled clinical studies in the literature regarding CMO's hypolipidemic effects in humans.

Design A prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels.

Methods 192 healthy volunteers were screened and eventually 160 of them with total cholesterol> 200 mg/dl participated in the study. They were randomized with a 2:1 ratio of receiving CMO capsules (containing 200 mg mastiha oil per capsule) and placebo for a total of 8 weeks respectively. 113 patients received CMO and 47 were randomized in the control group, and all of them completed the follow-up period.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Chios, Greece, 82100
    • Skylitseio General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- Increased total cholesterol >200 mg/dl, in adult volunteers (≥18 years old) of any gender, not amenable or not willing to receive pharmaceutical therapy.

Exclusion Criteria:

• Participation in any other study during the recruitment period
• Contribution in the design or accomplishment of the study
• Known cardiovascular disease (coronary artery disease, carotid artery disease, peripheral vascular disease, stroke, diabetes mellitus, aortic aneurysm)
• Patients in high or very high risk of CVD according to SCORE2
• Subjects amenable to pharmaceutical lipid-lowering regimens according to current guideline, or any other pharmaceutical regimen with hypolipidemic effects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chios Mastiha essential oil; 1 soft gel capsule containing 200 mg of CMO and 100 mg of other excipients being medium chain triglycerides, while the shell was made of bovine gelatin and glycerol	Dietary supplement: Chios Mastiha essential oil; 1 soft gel capsule containing 200 mg of CMO and 100 mg of other excipients being medium chain triglycerides, while the shell was made of bovine gelatin and glycerol
Placebo Comparator: Placebo; 1 soft gel capsule only 100 mg of other excipients being medium chain triglycerides, while the shell was made of bovine gelatin and glycerol	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cholesterol	Decrease in total cholesterol serum levels	8 weeks
LDL cholesterol	Decrease in LDL cholesterol serum levels	8 weeks
HDL cholesterol	Increase in HDL cholesterol serum levels	8 weeks
Triglycerides	Decrease in triglycerides serum levels	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	Decrease in glucose serum levels	8 weeks
Liver tests	Change in liver tests (SGOT, SGPT, gGT)	8 weeks
Renal tests	Change in renal tests (BUN, creatinine)	8 weeks
Electrolytes	Change in electrolyte levels (sodium, potassium)	8 weeks
Inflammation markers	Change in inflammation markers tests (CRP, uric acid)	8 weeks

Collaborators and Investigators

• Sponsor: AHEPA University Hospital
• Collaborators: Skylitseio General Hospital of Chios
• Investigators: Principal Investigator: Athanasios Kartalis, MD, Skylitseio General Hospital of Chios, Greece; Principal Investigator: Matthaios Didagelos, MD, PhD, AHEPA University General Hospital, Thessaloniki, Greece

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hypercholesterolemia; Hyperlipidemias
• Other Study ID Numbers: 4-19/02/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No